Chemical disinfectant and sterilant composition comprising acidic glutaraldehyde

ABSTRACT

The invention is an improved disinfectant and sterilant in a chemical form. The disinfectant and sterilant formulation is based upon glutaraldehyde which must be in acidic form. The normal pH range for the disinfectant and sterilant is 3.0-3.5, however, under controlled circumstances the range may be 2.5-7.0; as the disinfectant and sterilant must be acidic, it cannot be over pH 7.0. In use as a disinfectant by immersion, the items or materials remain immersed for up to ten minutes. As a sterilant, the immersion is between six and ten hours. The disinfectant and sterilant consists of a plurality of chemicals mixed with the glutaraldehyde as a solution.

BACKGROUND AND SUMMARY OF THE INVENTION

The invention relates to antiseptic and germicidal compositions and inparticular to disinfectants and sterilants. Specifically, it relates tochemical compositions for use as disinfectants and sterilants.

There have been many compositions developed for antiseptic andgermicidal cleansing purposes, but each in the prior art has had somelimitations as to the applications. For some the limitation has been theextent to which they could successfully disinfect. For others thelimitation has been the extent to which they could consistentlysterilize. Still others were limited because of the toxic effect on theskin or other organs of the user. Other compositions were limitedbecause of their corroding effect on metal, such as spotting ortarnishing.

The present invention has been developed to avoid or overcome theseprior art limitations especially in the general use solutions of thedisinfectant and sterilant. This is particularly so when used as adisinfectant and sterilant for inanimate objects.

The present invention has many uses for disinfecting or sterilizing hardsurfaces, such as counter tops, laboratory tables, laboratory equipment,hospital walls, and other such hard surface items or areas in medical,surgical or dental environments.

The disinfectant and sterilant of the present invention is specificallyintended as a means of fighting organisms that cause disease. Thedisinfectant and sterilant may be used in laboratories, operating rooms,patient-care rooms or areas, and other similar places in public orprivate facilities such as schools, hospitals, homes, factories, andsimilar locations.

The disinfectant and sterilant is intended for use to eliminate bacteriathat is found on hard surfaces as aforementioned. The use of the presentinvention may be for application by spraying, wiping, rinsing, dipping,brushing, or by other methods of application.

The basic ingredients of the formula for the disinfectant and sterilantcomposition, which is delineated in detail hereinafter, is composed ofglutaraldehyde, ortho phenyl phenol, para tertiary amyl phenol,benzotriazole, sodium aryl alkyl sulfonate, citric acid, and sodiumbiphosphate. The plurality of chemicals is mixed as a solution.

The disinfectant and sterilant is provided as a stock solution,thereafter, in activated form, it is diluted with water in variousproportions or ratios depending upon the level necessary to achieve aspecified end result. This is discussed in detail hereinafter.

Of particular note is the fact that in the prior art the use ofglutaraldehyde has usually been in the alkaline form, whereas in thepresent invention the use of glutaraldehyde is in the acid form.

The prior art disinfectants in the alkaline solutions tend to leave aresidue in the more concentrated forms. This could be an irritant.Several rinses may be required to remove the slippery residue.

The present invention is primarily for use as a disinfectant andsterilant on inanimate surfaces for disinfection and sterilization ofcontaminated areas. For example, on dental or surgical instruments thatare contaminated.

As a secondary use, the present invention may be used in a milder form,by dilution, as a hand disinfectant in health care offices,laboratories, and treatment rooms.

The normal pH range for the disinfectant and sterilant of this inventionis 3.0-3.5, however, under controlled circumstanes the range may be2.5-7.0; as the disinfectant and sterilant must be acidic, it cannot beover pH 7.0.

When used as a disinfectant by immersion, the items or materials remainimmersed for up to ten minutes. As a sterilant, the immersion is betweensix and ten hours.

As noted, the present invention uses the glutaraldehydes in the acidicform. In the prior art the glutaraldehydes in the alkaline form presentcertain disadvantages. Some of these disadvantages are: it needs anactivator of a special solution or powder to make it active; onceactivated, it then has a limited life of one to four weeks and must bedisposed of entirely; the composition, which is normally activated inapproximate amounts of a liter, is uneconomical if not used because itis dated at time of activation and must be discarded; the solutionyellows the skin due to a tanning action; it has a disagreeable odor;and it is corrosive.

In the present invention, the acid form of the glutaraldehydes needs noactivation and has a more or less indefinite shelf life of close to oneyear. The solution of the present invention permits mixing and dilutingjust the amount needed, thereby preserving the stock solution whichmakes it more economical. In this manner it does not need dating, forthe mixture being used is only what is needed.

In the prior art the corrosion of instruments (when used for dental andsurgical instrument disinfection or sterilization), the tanning effecton the skin, irritation of the skin and allergic dermatitis to the skin,its noxious odor, general toxicity, and the tarnishing of carbon steelinstruments were all undesirable problems. The present inventionovercomes these problems.

Use of the present invention is less irritating, because of the lowerconcentration in the useable dilutions. For example, in a 1:10 dilutionthere is no effect on the skin in a ten minute immersion. At the sametime, a one percent concentration of glutaraldehyde in the acidic formwill kill bacteria if contact is made.

The present invention has a much wider and universal use than thedisinfectants and sterilants of the prior art which were limited becauseof the prior art problems. The present invention may be used on and forall hard surfaces that are non-porous. Hard surface items includecatheters, scalpels, trays, bowls, dental mirrors, lights, and othersimilar equipment. Even cotton swabs may be soaked in it and then usedto disinfect.

In general use the present invention may be used for instrumentimmersion, wiping surfaces and instruments, dipping, and spraying (bypump or aerosol means).

The present invention may also be used by placing instruments in a traycontaining the disinfectant and sterilant in diluted solution form. Thisincludes all medical and other health care arrangements, includingveterinary, podiatry, hospital, nursing, and other health carefacilities or laboratories. Cages for laboratory animals and thelaboratory areas may be disinfected with the present invention. Inhousehold use the present invention may be used where ordinary spraysare used, such as in toilet bowls, animal areas, and kitchen areas. Thepresent invention is effective on items that cannot be heated orautoclaved, and includes rubber and plastics items.

In one of the milder forms, by diluting on a 1:80 basis (or in higherconcentrations where permissible) the present invention may be used insoaps for degerming the hands or as a presurgical lotion as a handdegerming agent.

It is, therefore, an object of this invention to provide a disinfectantand sterilant that is a chemical composition.

It is another object of this invention to provide a disinfectant andsterilant that may be used on hard surface inanimate objects.

It is also an object of this invention to provide a disinfectant andsterilant that may be used on living tissue.

It is yet another object of this invention to provide a disinfectant andsterilant that fights organisms that cause disease.

It is still another object of this invention to provide a disinfectantand sterilant that uses glutaraldehyde in acid form.

Further objects and advantages of the invention will become moreapparent in light of the following description of the preferredembodiments.

DESCRIPTION OF THE PREFERRED EMBODIMENTS

The formula of the present invention for a chemical disinfectant andsterilant is as follows:

    ______________________________________                                        glutaraldehyde (acidic)                                                                          15.46%                                                     ortho phenyl phenol                                                                              1.98%                                                      para tertiary amyl phenol                                                                        0.07%                                                      benzotriazole      0.24%                                                      sodium aryl alkyl sulfonate                                                                      0.24%                                                      citric acid        0.34%                                                      sodium biphosphate 8.07%                                                      water              73.60%                                                     TOTAL (By Weight)  100.00%                                                    ______________________________________                                    

The above formulation is the base stock solution and when used, ashereinafter described, it is diluted. The base stock solution is theconcentrated form and it is further diluted with water for clinical orgeneral use. The percentages are by weight of the ingredients to thetotal weight of the mixture.

It is to be noted that the aforementioned stock solution is shown as aliquid solution, however, it is to be understood that the reduction ortransformation to a dry powder state as a dry base stock chemicalcompound, for subsequent dissolving in water or other suitable solventto form the base stock solution, is within the scope and intent of thisinvention.

It is also to be understood that the mixing of the formula without thewater content as a liquid base stock chemical compound, for subsequentaddition of the water content to form the base stock solution, is alsowithin the scope and intent of this invention.

The formulation of the aforementioned chemical disinfectant andsterilant in a dry base stock chemical compound and in a liquid basestock chemical compound are means by which economical storage andshipment can be obtained in relation to the aforementioned base stocksolution which is of greater volume.

The glutaraldehyde in the formula is in acid form with a preferred pHrange of 3.0-3.5. However, a pH range of 2.5-7.0 is possible and useableunder controlled conditions. The glutaraldehyde for this invention mustbe acidic and, therefore, must not exceed a pH of 7.0, in that regardthe range slightly below the pH of 7.0 is desirable.

The glutaraldehyde and the sodium biphosphate are each a 10.0%concentration chemical compound, mixed into the formulation in weights,or percentages of the total weight, as noted hereinbefore. Theformulation given previously by percentages of the total weight for eachingredient, are shown below by actual weight of each ingredient for theformulation:

    ______________________________________                                                          Weight   Percent of                                         Ingredient        (grams)  Total Wgt.                                         ______________________________________                                        glutaraladehyde (acidic)                                                                        227.2    15.46                                              ortho phenyl phenol                                                                             29.0     1.98                                               para tertiary amyl phenol                                                                       1.0      0.07                                               benzotriazole     3.5      0.24                                               sodium aryl alkyl sulfonate                                                                     3.5      0.24                                               citric acid       5.0      0.34                                               sodium biphosphate                                                                              118.6    8.07                                               water             1081.5   73.60                                              TOTAL             1469.3   100.00                                             ______________________________________                                    

The citric acid removes a noxious odor and provides additionalacidification. The sodium biphosphate provides acidification for pHadjustment.

To activate the chemical disinfectant and sterilant for use, the basestock solution is diluted in controlled ratios with water. The normalrange of activated solutions is generally from a ratio of 1:10 to 1:80;that is one part base stock solution to nine parts water for a strongsolution, and one part base stock solution to seventy-nine parts waterfor a weak solution. These are for disinfecting purposes. Forsterilization the range is 1:5 to 1:10, depending upon the severity ofthe need.

The range of activated solutions from the ratio of 1:10 to the ratio of1:80 are for selected uses for disinfecting. The determination of theratio to use may be determined by test for the wide plurality ofapplications which exist. For example, the disinfection of kidneydialysis applications must be a ratio of 1:35, while for generalhospital or office disinfection it may be a ratio of 1:20.

The benzotriazole and sodium aryl alkyl sulfonate act as surfactants andcorrosion inhibitors. Sodium silicate (3.0%) or sodium nitrate (10 gramsper liter) may be substituted for the benzotriazole and such asubstitution is within the scope and intent of the present invention.

The weights for each ingredient, and their corresponding percentages ofthe total weight of the mixture, are for the optimal formula andpreferred embodiment of the invention of a chemical disinfectant andsterilant. However, it is to be understood that variations from thisoptimal formula of up to plus or minus ten percent of each weight areworkable and are within the scope and intent of this invention, anydifference in total weight being adjusted in the water content; thepercentages by weight being adjusted accordingly. Thus, the formula hasa range of weight for each ingredient with the optimal and preferredembodiment being as specifically listed.

In the use of the base stock solution of the chemical disinfectant andsterilant in the diluted state, solutions weaker than the 1:80 ratiobegin to lose their effectiveness or the ability to meet some desiredlevel of disinfection. While such weaker solutions may be used, they arenot recommended for best results. Whenever the solution being used is atsuch a weaker ratio it may be desirable to perform tests in order toassure the desired results are being obtained. For that reason suchweaker ratios are not recommended.

In using the present invention for disinfection by immersion, ultrasonicactivation of the mass will speed up the process of disinfection orsterilization.

The precautions and dangers encountered with the prior art disinfectantsand sterilants are greatly reduced by the present invention due to thereduced concentrations. This improvement is made possible by the factthat the disinfecting and sterilant agent glutaraldehyde is enhanced bythe synergistic action of the two phenols (ortho phenyl phenol and paratertiary amyl phenol) which are interactive and additive, making the sumgreater than any of the parts.

As can be readily understood from the foregoing description of theinvention, the present structured formulation of a chemical disinfectantand sterilant can be further structured in different modes offormulation to provide an ability to disinfect and sterilize objects.

Accordingly, modifications and variations to which the invention issusceptible may be practiced without departing from the scope and intentof the appended claims.

What is claimed is:
 1. A chemical disinfectant and sterilant, comprising:a basic formulation of chemical ingredients, said basic formulation of said chemical ingredients consisting of the following optimal quantities of said chemical ingredients, said optimal quantities being by weight of the total weight of said basic formulation: glutaraldehyde (acidic) 227.2 grams; ortho phenyl phenol 29.0 grams; para tertiary amyl phenol 1.0 grams; benzotriazole 3.5 grams; sodium aryl alkyl sulfonate 3.5 grams; citric acid 5.0 grams; sodium biphosphate 118.6 grams; and 1081.5 grams of water, the total mixture of said disinfectant and sterilant having a total optimal weight of 1469.3 grams, said respective weights of said chemical ingredients and said water being 15.46% glutaraldehyde (acidic), 1.98% ortho phenyl phenol, 0.07% para tertiary amyl phenol, 0.24% benzotriazole, 0.24% sodium aryl alkyl sulfonate, 0.34% citric acid, 8.07% sodium biphosphate, and 73.60% water, said formulation of said chemical ingredients forming a base stock solution.
 2. A chemical disinfectant and sterilant as recited in claim 1, wherein said chemical ingredients, including said principal chemical ingredient, are liquids.
 3. A chemical disinfectant and sterilant as recited in claim 1, wherein said chemical ingredients, including said principal chemical ingredient, are dry ingredients in a powder-like consistency, said dry ingredients being suitably dissolved when being readied for use.
 4. A chemical disinfectant and sterilant as recited in claim 1, wherein said glutaraldehyde, being acidic, has a pH range held within 3.0 to 3.5.
 5. A chemical disinfectant and sterilant as recited in claim 1, wherein said glutaraldehyde, being acidic, has a pH range of 2.5 to 7.0.
 6. A chemical disinfectant and sterilant as recited in claim 1, wherein said glutaraldehyde, being acidic, has a pH range not exceeding 7.0.
 7. A chemical disinfectant and sterilant as recited in claim 1 and additionally, ultrasonic activation of the mass, said ultrasonic activation speeding up the process of disinfection. 